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Product Summary

PRESCRIPTION REQUIRED

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

OXCARBAZEPINE - ORAL

(ox-kar-BAY-zih-peen)

COMMON BRAND NAME(S): Trileptal

USES: This medication is used to treat seizure disorders (epilepsy). It may be used with other seizure medications as determined by your doctor.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using oxcarbazepine and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth, usually twice daily. This drug may be taken with or without food. The dosage is based on your medical condition (including pregnancy) and response to therapy. It is important to take all doses on time to keep the level of medication in your blood constant. Take doses at evenly spaced intervals. Do not skip doses. Do not suddenly stop taking this drug without your doctor's approval since seizures may reoccur. Notify your doctor if seizure control worsens.

SIDE EFFECTS: Dizziness, drowsiness, fatigue, nausea, vomiting, headache, trouble sleeping, acne, dry mouth, or constipation may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. Tell your doctor immediately if you develop any of these serious side effects: double vision, change in vision, involuntary eye movements, difficulty speaking, difficulty concentrating, loss of coordination, trouble walking (abnormal gait), uncontrolled muscle movements (tremor), dulled sense of touch. Tell your doctor immediately if you develop any of these unlikely but very serious side effects: easy bleeding/bruising, chest pain, persistent sore throat, stomach/abdominal pain, bloody stool, dark urine, change in amount of urine, yellowing of eyes/skin. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: fever, rash, itching/swelling (especially of the face/tongue/throat/lymph nodes), joint/muscle pain, severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking oxcarbazepine, tell your doctor or pharmacist if you are allergic to it; or to carbamazepine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Tell your doctor your medical history, including: kidney disease, decreased sodium blood levels (hyponatremia), recent seizures. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor. This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription medication you may use, especially: calcium channel blockers (e.g., verapamil, felodipine), cyclosporine, other seizure control medication (e.g., carbamazepine, phenytoin, phenobarbital, valproic acid), a certain combination HIV medication (elvitegravir/cobicistat/emtricitabine/tenofovir). This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. Tell your doctor if you take any drugs that make you drowsy, such as: medicine for sleep, sedatives, tranquilizers, anti-anxiety drugs (e.g., diazepam), narcotic pain relievers (e.g., hydrocodone, codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), muscle relaxants, antihistamines that cause drowsiness (e.g., diphenhydramine). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about the safe use of those products. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: It is recommended you wear or carry identification indicating you are using this drug. Do not share this medication with others. Laboratory and/or medical tests (e.g., sodium levels, pregnancy tests) may be performed to monitor your therapy.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) in a tight container away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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